Health and Fitness : Iowa hospitals oppose mandatory reporting of major medical errors

By Clark Kauffman

A bill that would require Iowa’s medical facilities to inform regulators of any serious medical errors is again facing opposition from the state’s hospitals.

Senate File 2185 would require Iowa hospitals, ambulatory surgical centers and birth centers to report any “serious reportable events” — sometimes called “never events” — to the Iowa Department of Inspections, Appeals and Licensing.

Such events include injuries or deaths associated with the use of contaminated drugs, major medication errors, the discharge of newborn infants to the wrong patients, surgery on the wrong body part or wrong patient, and artificial insemination with the wrong sperm or donor egg.

Recently, the nonprofit National Quality Forum, an affiliate of the Joint Commission, which accredits many of the nation’s hospitals, reported that more than 30 states and the District of Columbia have incorporated the organizations’ list of reportable events into their own event-reporting programs — some of which require reporting to state regulators, and some of which treat such reporting as voluntary.

Although Senate File 2185 includes provisions that appear intended to elicit support from the medical community — such as a requirement that any reports made to DIAL exclude information that would identify any individual health care professionals involved in an incident — it has, as in years past, run into opposition from the state’s hospitals.

The Iowa Hospital Association, UnityPoint Health and MercyOne are all registered in opposition to the bill. Executives and lobbyists with all three entities did not respond to the Iowa Capital Dispatch’s inquiries last week and Monday about their stance on the legislation.

The bill passed a subcommittee Feb. 12 and moved to the Senate Health and Human Services Committee. The full panel is so far not scheduled to meet this week. Most bills need approval from a committee in either the House or Senate before the end of this week to remain eligible for debate this session.

Fight over reporting dates back at least 16 years

The push to require the sharing of information on serious reportable events in Iowa dates back at least 16 years, to when the Iowa Hospital Licensing Board, dominated by hospital officials, refused to vote on a proposal that would have created an administrative rule mandating such reports be made to the state.

The board’s refusal to vote on the proposal angered Dean Lerner, then the head of the state inspections department, and prompted him to walk out of the meeting and declare that “special interests have taken over government.”

Lannie Miller was then one of the board’s lay members, tasked with representing the interests of average Iowans. He stopped attending meetings at the time, saying he was “disgusted” with the way the group handled issues.

“It’s the fox guarding the hen house,” he said then. “It’s made up of people involved in the hospitals. I’m fed up. The hell with it.”

Since then, legislation has been drafted several times to codify the requirement in state law, but the idea has yet to win the approval of state lawmakers.

Sen. Mark Lofgren, a Republican from Muscatine, introduced this year’s version of the bill, and said he believes it would lead to better-informed consumers and lawmakers.

“As legislators, we are very data driven in our decision making, and so is today’s average consumer,” he said. “Consumers research all they can when they vacation, and when they plan for the purchase of a car or a home, but when it comes to searching for safe health care, the information we need is not very accessible. Patients should be able to make the best decisions possible related to their health care. Hospitals don’t share this information and the websites for the Iowa Board of Medicine as well as the Iowa Department of Inspections, Appeals and Licensing — the oversight for our health care in the state — are very cumbersome and are not patient friendly.”

Lofgren said the purpose of the bill is to facilitate quality improvement in the health care system without punishing health care facilities. In fact, the bill stipulates that “no other state agency or licensing board is required to conduct an investigation” into any serious reportable event once DIAL is informed of the matter.

The bill would require that the hospitals and other facilities, after reporting an incident to DIAL, conduct a root cause analysis of the event and either implement a corrective action plan or explain why no such plan is needed.

The bill also includes confidentiality provisions that indicate information on serious reportable events relayed to DIAL by a professional licensing board, as well as any corrective action plans, are to be sealed from public view. It’s not clear whether the self-reports from hospitals and medical facilities to DIAL would also be treated as confidential.

Backers say the bill promotes transparency 

Lerner, who is now retired but remains active in patient advocacy, said last week the health care industry “maintains a stranglehold” on state government in Iowa, despite the millions the industry collects from taxpayers through Medicaid and Medicare.

“Why else would Iowans be denied the absolute right to know about horrible harms — unforgivable, preventable never-events — that have occurred under their care?” he asked.  “In a just world, the providers who’ve opposed transparency shouldn’t be allowed another taxpayer benefit. Instead, their wish lists are granted and Iowans suffer.”

The Iowa Association for Justice, which represents the state’s trial lawyers, is registered as favoring the bill. The organization’s executive director, Andrew Mertens, noted that over the past 27 years, estimates of the number of Americans killed each year by medical error have increased from 98,000 to 440,000.

A report issued 10 years ago, Silently Harmed, suggested that as many as 2,400 Iowans die each year from medical errors, Mertens said.

“It’s important to get trackable data to determine whether this is a growing problem or the reporting is simply improving,” he said. “I think a key factor in all of this is that in Iowa, we have essentially legislated medical malpractice lawsuits out of existence. Now, they are still being filed and are still being pursued, but it is so much more rare, and so much more difficult, today — even when you have a preventable death from negligent care.”

With individual patients and families unable to seek accountability through the courts, Mertens said, it becomes even more important that state regulators be informed of serious incidents that cause harm.

Mertens said that while it’s not clear how much of the reported information would ever be shared with the public, he hopes that useful data, at least in the aggregate, will eventually be released should the bill become law.

“Absolutely, the reporting this bill would require falls short of making this a tool that could be used by patients in terms of being able to compare care providers and facilities,” he said. “Unfortunately, this bill just wouldn’t be useful for patients to acquire that sort of information for their own safety. Although that is needed, this bill doesn’t go there. Even so, we consider it a step in the right direction.”